Use of Electrical Safety Standards in 510(k) approval process

A

aoldendo

#1
Hi folks:

We have a Class II device with a power supply which is external to the unit (i.e. just like a laptop battery charger).

My question is this: for 510(k) approval of the device (whether it be traditional, abbreviated or special), must we test to IEC 60601-1 and IEC 60601-1-2 or declare conformity with both of those standards?

Thanks!
 
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Stijloor

Staff member
Super Moderator
#2
Hi folks:

We have a Class II device with a power supply which is external to the unit (i.e. just like a laptop battery charger).

My question is this: for 510(k) approval of the device (whether it be traditional, abbreviated or special), must we test to IEC 60601-1 and IEC 60601-1-2 or declare conformity with both of those standards?

Thanks!
Can a Medical Device expert help?

Thank you!!

Stijloor.
 

Michael Malis

Quite Involved in Discussions
#3
Hi folks:

We have a Class II device with a power supply which is external to the unit (i.e. just like a laptop battery charger).

My question is this: for 510(k) approval of the device (whether it be traditional, abbreviated or special), must we test to IEC 60601-1 and IEC 60601-1-2 or declare conformity with both of those standards?

Thanks!
Please clarify if I am missing something, but you only can declare conformity with those standards if you have results in your hands!

If results are Acceptable, than you declare conformity and will be able to provide the results if FDA asks...
 
Last edited:

Le Chiffre

Quite Involved in Discussions
#4
I don't have a definitive answer, but since you're intending to file a 510(k), it's worth looking at what your predicate(s) did and what the typical is for your product code.
 

bio_subbu

Super Moderator
#5
Hi folks:

We have a Class II device with a power supply which is external to the unit (i.e. just like a laptop battery charger).

My question is this: for 510(k) approval of the device (whether it be traditional, abbreviated or special), must we test to IEC 60601-1 and IEC 60601-1-2 or declare conformity with both of those standards?

Thanks!
Hi

The testing depends on the Product Code for the device. For example, Product Code EWG, (ENT microsurgical carbon dioxide laser), have two recognized consensus standards that apply to it:

Device -----------------------laser, ent microsurgical carbon-dioxide

Regulation Description -------- Ear, nose, and throat microsurgical carbon dioxide laser.

Regulation Medical Specialty -- Ear Nose & Throat

Review Panel------------------Ear Nose & Throat

Product Code -----------------EWG

Submission Type --------------510(k)

Regulation Number-------------874.4500

Device Class ------------------2

GMP Exempt? -----------------No

Recognized Consensus Standards

* IEC 60825-1 Ed. 2.0 (2007) Safety of laser products - Part 1: Equipment classification, and requirements
* IEC 60601-2-22 (1995) Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment - Edition 2.0

Third Party Review

* Eligible for Accredited Persons Program

Accredited Persons

* citech
* intertek testing services
* kema quality b.v.
* regulatory technology services, llc
* tuv rheinland of north america, inc.
* tuv sud america inc.
* underwriters laboratories, inc.


There should be testing results in your company’s records that demonstrate that the device conforms to the recognized consensus standard/s for that device. In an Abbreviated or Special 510(k), you can simply include a Statement of Conformance/Affirmation of Conformance.

Also, check if your predicate device was tested to both IEC 60601-1 and IEC 60601-1-2 and test your device the same way the predicate was tested.
 
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